A Randomised Phase III Study of Elacytarabine vs. Investigator’s Choice in Patients with Late Stage Acute Myeloid Leukaemia
A Randomised Phase III Study in Patients with Late Stage Acute Myeloid Leukaemia, comparing the efficacy, measured as overall survival (OS), of elacytarabine and investigator’s choice.
Clavis Pharma ASA
350 participants
Aug 17, 2010
Interventional
Conditions
Summary
This study compares the safety and effectiveness of different types of chemotherapy to treat late stage acute myeloid leukaemia. Who is it for? You can join this study if you are aged 18 years or over and have been diagnosed with acute myeloid leukaemia, for which you have undergone two or three previously unsuccessful chemotherapy regimens. Trial details In this study, participants are randomly (by chance) divided into two groups. One group will receive chemotherapy with the drug, Elacytarabine. This will be administered intravenously (into the vein) continuously for 3 days every 3 weeks. The investigator wil decide how long it is beneficial for you to receive treatment.The other group will receive one of a number of other chemotherapy regimens used to treat leukaemia. The treatment administered will be selected by the treating doctor based on your condition. Participants will be regularly monitored in order to determine the safety and effectiveness of treatment.
Eligibility
Inclusion Criteria22
- Patients with a confirmed diagnosis of AML according to WHO classification
- (excluding acute promyelocytic leukaemia) who have received two or three
- previous induction/re-induction regimens. One of the (re-)induction regimens could
- be stem cell transplantation (SCT) for achievement of remission. Maintenance and
- consolidation (including SCT) may have been given, but are not counted as
- previous regimens.
- Patient’s bone marrow aspirates and/or biopsies must contain > 5 % leukaemic
- blast cells or patient must have biopsy-proven extramedullary AML, or patient’s
- peripheral blood shows occurrence of leukaemic blast cells
- Patients must
- a. have never attained CR or CRi (primary refractory), or
- b. have failed initial induction therapy, and have attained CR or CRi after
- salvage therapy(ies), and then relapsed within < 6 months, or
- c. have attained CR or CRi after initial induction therapy and relapsed within
- <12 months, and failed to respond to salvage therapy(ies), or
- d. have relapsed after the latest CR or CRi within < 6 months
- Patients younger than 65 years should have received previous treatment with
- cytarabine
- Patients must have recovered from previous bone marrow and/or stem cell
- transplantation to a stage that the patient can tolerate the study treatment. There is
- no restriction on number of regimens or type of treatment administered for
- maintenance or consolidation during previous stages of the disease
Exclusion Criteria8
- Persistent clinically significant toxicities from previous chemotherapy
- Impairment of hepatic or renal function to such an extent that the patient, in the opinion of the investigator, will be exposed to an excessive risk if entered into this
- clinical study
- Active heart disease including myocardial infarction within previous 3 months,
- symptomatic coronary artery disease, arrhythmias not controlled by medication, or
- uncontrolled congestive heart failure. Any NYHA grade 3 or 4.
- Patients receiving any anti-leukaemic agents within the last 4 weeks. Hydroxyurea, however, is allowed for up to 12 hours prior to study treatment.
- Patients receiving any investigational treatment within the last 14 days
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Interventions
Elacytarabine continous infusion days 1-5, every 3 weeks, dose 2000 mg/m2/d. 1-2 treatment courses should be administered for remission induction, and 1-2 courses for consolidation. Patients who benefit from the treatment may receive repeated courses of study drug at the discretion of the investigator, even if remission is not attained.
Locations(12)
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ACTRN12611000474954